InterStim iCon
GUDID 00613994572059
PRGMR 3037 INTERSTIM PATIENT SW UPDATE
MEDTRONIC, INC.
Neuromuscular electrical stimulation system programmer Neuromuscular electrical stimulation system programmer Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered Implantable incontinence-control electrical stimulation system programmer, battery-powered| Primary Device ID | 00613994572059 |
| NIH Device Record Key | 161023d4-997e-4da7-b111-9b8891ae0701 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InterStim iCon |
| Version Model Number | 3037 |
| Company DUNS | 796986144 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994572059 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970004
FDA Product Code
| EZW | Stimulator, electrical, implantable, for incontinence |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [InterStim iCon]
| 00613994639639 | PROGRAMMER 3037 INTERSTIM PATIENT BOWEL |
| 00613994572059 | PRGMR 3037 INTERSTIM PATIENT SW UPDATE |
Trademark Results [InterStim iCon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERSTIM ICON 78398840 3177801 Live/Registered |
Medtronic, Inc. 2004-04-08 |
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